# K142520: Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 20, 2014 after 73 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962616 (1996). 53 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110069: Smith & Nephew, Inc Spatialframe V4.1 Web-Based Software, Smith & Nephew, Inc. (2011) Summary page 5.
- K093047: Smith & Nephew Circular Fixation System, Smith & Nephew, Inc. (2010) Summary page 5.

## Most influential descendants
- K210953: SMART Taylor Spatial Frame (2021), 2 descendants of its own
- K253202: Hoffmann LRF System (2025), 0 descendants of its own
- K221792: Acute QC Strut and Components (2022), 0 descendants of its own

## Recalls of this device
- Dec 13, 2017 · Class II · Z-0409-2018: In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted in the preview images on

## Indications for use
Smith & Nephew External Fixation Systems 1. Post-Traumatic joint contracture which has resulted in loss of range of motion 2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 3. Open and closed fracture fixation 4. Pseudoarthrosis of long bones 5. Limb lengthening by epiphyseal or metaphyseal distraction 6. Correction of bony or soft tissue deformities 7. Correction of segmental bony or soft tissue defects 8. Joint arthrodesis 9. Infected fractures or nonunions

Source page: https://510kreport.com/device/K142520
Methodology: https://510kreport.com/methodology